Claims
- 1. An intravenous lead comprising:
an elongate flexible lead body made of an electrically insulative material, the lead body having a proximal end and a distal end; at least one lumen extending through the lead body from the proximal end toward the distal end, the at least one lumen having a first opening through the proximal end and a second opening through the distal end; a conductive member extending through the lead body from the proximal end toward the distal end of the lead body; at least one electrode electrically coupled to the conductive member; and a hemostasis mechanism comprising a polymer membrane operably coupled with the at least one lumen.
- 2. The lead as recited in claim 1, wherein the hemostasis mechanism is located near the distal end of the lead.
- 3. The lead as recited in claim 2, wherein the electrode is located near the distal end of the lead body and the hemostasis mechanism is located distal of the electrode.
- 4. The lead as recited in claim 1, wherein the hemostasis mechanism is disposed within the lead lumen.
- 5. The lead as recited in claim 1, wherein the hemostasis mechanism is attached to and carried by the lead.
- 6. The lead as recited in claim 1, wherein the hemostasis mechanism further comprises a housing in which the polymer membrane is disposed.
- 7. The lead as recited in claim 6, wherein the housing is tubular.
- 8. The lead as recited in claim 6, wherein the housing is comprised of silicone rubber or polyurethane or hydrogel.
- 9. The lead as in claim 8, wherein the housing is adhesively bonded to an interior surface of the lead.
- 10. The lead as recited in claim 6, wherein the housing is comprised of titanium.
- 11. The lead as recited in claim 10, wherein the housing is laser welded to the lead proximal to an end of the electrode.
- 12. The lead as recited in claim 10, wherein the housing is adhesively bonded to the lead proximal to an end of the electrode.
- 13. The lead as recited in claim 6, wherein the housing further comprises an indentation constructed and arranged to mate with the lead body.
- 14. The lead as recited in claim 13, wherein the indentation is located at the proximal end of the housing and defines a proximally facing annular shoulder which meets an exterior portion of the distal end of the lead body.
- 15. The lead as recited in claim 6, wherein the housing comprises an annular recessed area wherein the polymer membrane is held.
- 16. The lead as recited in claim 6, wherein the polymer membrane is held within the housing by an interference fit.
- 17. The lead as recited in claim 6, wherein the polymer membrane is adhesively bonded within the housing.
- 18. The lead as recited in claim 1, wherein the hemostasis mechanism includes a valve.
- 19. The lead as recited in claim 18, wherein the valve is comprised of silicone.
- 20. The lead as recited in claim 19, wherein the valve is a bicusp valve.
- 21. The lead as recited in claim 19, wherein the valve is a tricusp valve.
- 22. The lead as recited in claim 19, wherein the valve is a quad cusp valve.
- 23. The lead as recited in claim 1, wherein the lumen thereof is filled with a sterile fluid, maintained in the lumen by a hydraulic lock provided by the hemostasis membrane.
- 24. The lead as recited in claim 1, wherein the hemostasis mechanism is removably attached to the lead and is disposable.
- 25. An intravenous lead comprising:
an elongate flexible electrically insulative lead body having a proximal end, a distal end, and a lumen extending therethrough, the lumen having a first proximal end opening and a second distal end opening; a conductive member extending through the lead body from the proximal end toward the distal end of the lead body; an electrode electrically coupled to the conductive member; and a polymer membrane operably coupled with the lead lumen at the proximal end of the lead body.
- 26. An intravenous lead comprising:
an elongate flexible lead body made of an electrically insulative material, the lead body having a proximal end and a distal end and being adapted for implantation on or about the left side of the heart, the lead body having an interior portion defining a lumen extending through the lead body from the proximal end toward the distal end, the lead body having a first proximal end opening and a second distal end opening; a conductive member extending through the lead body from the proximal end toward the distal end of the lead body; an electrode located near the distal end of the lead body, the electrode electrically coupled to the conductive member; and a hemostasis mechanism operably coupled with the lead and located near the proximal end of the lead, the hemostasis mechanism comprising a polymer membrane.
- 27. The lead as recited in claim 26, wherein the hemostasis mechanism is disposed within the lead lumen.
- 28. The lead as recited in claim 26, wherein the lead is an over-the-wire left ventricular lead having an atraumatic tip.
- 29. The lead as recited in claim 26, wherein the polymer membrane is comprised of silicone rubber or polyurethane or a hydrogel.
- 30. The lead as recited in claim 26 further comprising a terminal pin, the hemostasis mechanism attached to and extending from the terminal pin.
- 31. The lead as recited in claim 26 further comprising a terminal pin, wherein the hemostasis mechanism is integral with and disposed within the terminal pin.
- 32. The lead as recited in claim 31 further comprising a port, and wherein the hemostasis mechanism further comprises a grommet, the hemostasis mechanism being removably connected to the terminal pin by the grommet.
- 33. The lead as recited in claim 26, wherein the polymer membrane defines at least one hole to allow penetration of the membrane with a needle or a guide wire.
- 34. The lead as recited in claim 26, wherein the polymer membrane defines at least one slit adapted to allow penetration of the membrane with a needle or a guide wire.
- 35. A hemostasis mechanism adapted for use with an implantable intravenous lead, the hemostasis mechanism comprising a tubular housing having a polymer membrane located therein.
- 36. The hemostasis mechanism of claim 35, wherein the membrane comprises a valve.
- 37. The hemostasis mechanism of claim 35, wherein the polymer membrane is disposed at the proximal end of the lead body.
- 38. A method comprising:
providing an over-the-wire left ventricular lead comprising a lead body having a proximal end, a distal end and a terminal pin at the proximal end thereof, the lead body having an interior portion defining a lumen therethrough; providing a hemostasis mechanism comprising a housing with a polymer membrane therein, the polymer membrane defining at least one aperture for a needle or guide wire to penetrate the polymer membrane; attaching the hemostasis mechanism to the lead by attaching the housing to the terminal pin; inserting a needle in the at least one aperture of the membrane and filling the lead lumen with a sterile fluid; withdrawing the needle from the membrane, whereby the polymer membrane closes sufficiently to maintain a hydraulic lock on the fluid in the lumen; passing a guide wire through the membrane and inserting the guide wire into the lead lumen; and deploying the lead, whereby the column of saline is maintained in the lead lumen by the membrane, the column of sterile fluid preventing blood from entering the lead lumen.
- 39. The method of claim 38, wherein deploying the lead includes deploying the lead on the left side of a heart.
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is related to U.S. patent application Ser. No. 09/133,310 filed Aug. 12, 1998, entitled “EXPANDABLE SEAL FOR USE WITH MEDICAL DEVICE AND SYSTEM”, which is incorporated herein by reference.